Berkhout-Byrne Noeleen, Kallenberg Marije H, Gaasbeek André, Rabelink Ton J, Hammer Sebastiaan, van Buchem Mark A, van Osch Matthias J, Kroft Lucia J M, Boom Henk, Mooijaart Simon P, van Buren Marjolijn
a Department of Nephrology , Leiden University Medical Center , Leiden , The Netherlands.
b Department of Gerontology and Geriatrics , Leiden University Medical Center , Leiden , The Netherlands.
Curr Med Res Opin. 2017 Nov;33(11):2057-2064. doi: 10.1080/03007995.2017.1341404. Epub 2017 Jul 11.
Older patients with end stage renal disease (ESRD) are at increased risk for cognitive decline, but detailed studies of the magnitude of cognitive decline on dialysis or comprehensive conservative management (CCM) are lacking and the underlying pathophysiological mechanisms have poorly been studied.
To describe the rationale and design of the COPE study. Study objectives are as follows. Firstly, to examine the severity of cognitive impairment in older patients reaching ESRD before dialysis and the rate of decline after dialysis or CCM initiation. Secondly, to study the association of blood biomarkers for microvascular damage and MRI derived measurements of small vessel disease with the rate of cognitive decline. Thirdly, to examine to what extent cardiac function is related to brain structure and perfusion in patients reaching ESRD. Finally, to study the association of cognitive and functional capacity with quality of life in pre-dialysis patients, as well as after dialysis or CCM initiation.
The COPE study is a prospective, multicenter cohort study in the Netherlands, including prevalent and incident pre-dialysis patients ≥65 years old with eGFR ≤20 ml/min/1.73 m, awaiting either dialysis or CCM initiation. At baseline extensive data is collected including a comprehensive geriatric assessment and laboratory tests. Brain and cardiac MRI for analysis of structural and functional abnormalities are performed at baseline and repeated following therapy change. All other measurements are repeated annually during four years of follow up, including an extra evaluation six months after initiation of dialysis.
Knowledge of the magnitude of cognitive decline and its underlying pathophysiological mechanism, as well as its impact on functionality and quality of life can eventually help to postulate an algorithm for well balanced decision making in treatment strategies in older patients reaching ESRD.
The COPE study is registered on www.ccmo.nl (number: NL46389.058.13).
老年终末期肾病（ESRD）患者认知功能下降风险增加，但缺乏关于透析或综合保守治疗（CCM）时认知功能下降程度的详细研究，且对其潜在病理生理机制的研究较少。
描述COPE研究的基本原理和设计。研究目标如下。第一，检查老年ESRD患者透析前的认知障碍严重程度以及透析或开始CCM治疗后的下降速率。第二，研究微血管损伤的血液生物标志物和MRI衍生的小血管疾病测量值与认知下降速率的关联。第三，检查ESRD患者的心脏功能与脑结构和灌注的相关程度。最后，研究透析前患者以及透析或开始CCM治疗后患者的认知和功能能力与生活质量的关联。
COPE研究是一项在荷兰进行的前瞻性多中心队列研究，纳入年龄≥65岁、估算肾小球滤过率（eGFR）≤20 ml/min/1.73 m²、等待透析或开始CCM治疗的透析前现患和新发病例患者。在基线时收集大量数据，包括全面的老年医学评估和实验室检查。在基线时进行脑和心脏MRI以分析结构和功能异常，并在治疗改变后重复检查。在四年随访期间每年重复进行所有其他测量，包括透析开始后六个月的额外评估。
了解认知功能下降的程度及其潜在病理生理机制，以及其对功能和生活质量的影响，最终有助于制定算法，以便在老年ESRD患者的治疗策略中做出平衡的决策。
